Study ID: GOULD
GOULD: Getting to an improved understanding of low-density lipoprotein cholesterol and dyslipidemia management – a registry of high cardiovascular risk subjects in the United States
This trial is studying patients who have been diagnosed with high low-density lipoprotein (LDL) cholesterol levels or dyslipidemia, which is defined as elevated total or (LDL) cholesterol levels, or low levels of high-density lipoprotein (HDL) cholesterol. A diagnosis of dyslipidemia puts patients at a higher risk for heart disease and stroke.
All subjects receive treatment. There are three study arms: two control groups and one group that will receive a new class of injectable LDL cholesterol-lowering drug (called a PCSK9 inhibitor).
This is a prospective, multicenter, observational cohort study with retrospective component/chart review of ASCVD subjects that is designed to describe practice patterns of cholesterol management in such subjects in the U.S. Up to 1 year of retrospective lipid treatment, lipid measurement patterns, and CV data in subjects with ASCVD meeting inclusion/exclusion criteria at enrolled clinical sites will be captured.
- Cohort 1 (about 500 subjects) will be treated with a PCSK9i at baseline. Proof consisting of a current prescription for an approved PCSK9i and subject confirmation that they have taken a PCSK9i within 30 days prior to enrollment is necessary.
- Cohort 2 (about 2,000 subjects) with LDL-C ≥ 100 mg/dL; confirmation of LDL-C ≥100 mg/dL with no change in LLT for 4 weeks.
- Cohort 3 (about 2,500 subjects) with LDL-C 70-99 mg/dL; confirmation of LDL-C 70-99 mg/dL with no change in LLT for 4 weeks.
- Must have been diagnosed with high LDL or dyslipidemia
- Must agree to undergo treatment and follow-up care for up to three years